Patricia Maldonado

Patricia Maldonado has over 20 years of experience in quality assurance, compliance, and research in the pharmaceutical and biotech industries. Patricia is currently working as a Senior Manager in Research Quality Assurance at Sage Therapeutics, where they assess GLP compliance risk areas, provides guidance for nonclinical programs, and contributes to continuous quality improvement.

Before their current role, Patricia worked as a Consultant in Quality R&D at Elanco, where they advised on compliance and quality matters, conducted oversight and audits for studies, and executed self-inspections of internal processes. Prior to that, they were a Senior Quality Associate at Brooks Life Sciences, where they developed and implemented policies and procedures to achieve quality goals and provided compliance guidance to global personnel.

Patricia also has experience at Dow AgroSciences as a GLP Quality Assurance Auditor, where they monitored all aspects of studies and participated in audits performed by external government agencies. Patricia also worked as a Lead Chemist, conducting studies in support of biotech product registrations and assisting with requests for information. Additionally, they served as a Chemist II, planning and executing complex studies and leading training for new employees.

Earlier in their career, Patricia worked as a Quality System Specialist at Eurofins Lancaster Laboratories, where they managed events and incidents and conducted investigations. Patricia also served as a Technology Transfer Engineer at Quadraspec, leading projects in method and process development, and as a Quality Control Chemist, developing and validating QC test methods.

Patricia began their career as a Quality Control Technician at Eli Lilly, involved in the start-up of the Fermentation QCL and conducting research projects to optimize procedures and practices.

Overall, Patricia Maldonado has a strong background in quality assurance, compliance, and research, with expertise in GLP, GMP, vGCP, and regulatory guidelines. Patricia has a proven ability to develop and implement quality systems and procedures, provide compliance guidance, conduct audits, and lead cross-functional teams.

Patricia Maldonado has a strong educational background in the field of science. Patricia obtained their Bachelor of Science (B.S.) degree in Chemistry from the Pontifical Catholic University of Puerto Rico, where they studied from 1995 to 1999. Following this, Patricia pursued further education and earned a Master of Science (M.S.) degree in Biotechnology from The Johns Hopkins University, completing their studies from 2008 to 2011.

In addition to their academic achievements, Patricia has also obtained several certifications to enhance their professional qualifications. Patricia is a Registered Quality Assurance Professional - Good Laboratory Practice (RQAP-GLP), which they obtained from the Society of Quality Assurance in April 2019. Furthermore, they hold the certification of Certified Quality Auditor (CQA) from ASQ - World Headquarters, which they acquired in December 2016. Additionally, Patricia has the certification of Six Sigma Green Belt Project Leader, obtained from Dow AgroSciences in October 2016.